AB0472 FILGOTINIB FOR RHEUMATOID ARTHRITIS - AN OBSERVATIONAL STUDY TO ASSESS CLINICAL EFFECTIVENESS IN NHS LOTHIAN
Authors: C. Box, E. Swann, H. Harris, N. Mckay
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Filgotinib (Jyseleca) is a Janus-kinase (JAK) inhibitor which in 2021 was approved for use in the UK in moderate or severe rheumatoid arthritis (RA) either as monotherapy or in combination with Methotrexate. A reduced dose of 100 mg is recommended for patients aged 75 years or over, or with moderate or severe renal impairment. Clinical efficacy of filgotinib alongside a conventional disease-modifying anti-rheumatic drug (cDMARD) was demonstrated in the FINCH 1 and FINCH 2 trials [1,2] but evidence of real-world effectiveness is currently limited. <h3>Objectives</h3> To describe a cohort of patients prescribed filgotinib (Jyseleca) for RA in NHS Lothian and assess clinical response and discontinuation rates in regular clinical practice. <h3>Methods</h3> The electronic patient record was reviewed for patients prescribed filgotinib in NHS Lothian between December 2021 and August 2022. Baseline data was recorded including time since diagnosis of RA, previous and concurrent treatment, duration of treatment with filgotnib and discontinuation reason if applicable. Comorbidities of interstitial lung disease (ILD), prior venous thromboembolism (VTE), major adverse cardiovascular events (MACE) or malignancy were recorded. Steroid prescriptions at the time of commencing filgotinib were recorded. DAS-28 scores within 6 months prior to starting filgotinib were recorded where they had been performed, along with most recent DAS-28 scores. <h3>Results</h3> 145 patients were prescribed filgotinib for RA; 106 females and 39 males. Median age was 64 years. Median treatment duration was 213 days. 35 (24.1%) patients were treated with the reduced 100mg dose. 14 (9.7%) discontinued treatment. 120 (82.8%) were previously treated with an alternative biologic DMARD. 59 (40.7%) had failed multiple biologic DMARDs of different classes. 19 (13.1%) switched directly to filgotinib from an alternative JAK inhibitor. Pre-treatment DAS-28 scores were recorded in 53 (36.6%), with a mean score of 5.07. DAS-28 scores following commencement of filgotinib were recorded in 29 (20.0%), with a mean score of 3.50. Pre-treatment tender (TJC) and swollen (SJC) joint counts were recorded in 86 (59.3%), with mean TJC 10.35 and SJC 6.50. Post-treatment counts were recorded in 46 (31.7%), with mean TJC 4.65 and SJC 2.91. Pre-treatment patient visual assessment score (VAS) of global health was recorded in 71 (49.0%), with mean VAS 62. Post-treatment VAS was recorded in 32 (22.1%), with mean VAS 43. 12 (8.3%) patients had DAS-28 scores recorded before and after. 7 were classed as a good response by EULAR criteria, 2 were a moderate response, and 3 were non-responders. <h3>Conclusion</h3> The drug survival rate of 90.3% after efficacy assessment at clinical review suggests a good tolerance, patient acceptability and clinical effectiveness. This Edinburgh-based, real-world, unselected patient cohort includes a high rate of multidrug-resistant RA yet sustains a high drug survival rate at 6 months. The cohort is limited by the lack of accurate DAS-28 recording in the clinical record. This may in part reflect the Lothian model of treating imaging-confirmed synovitis in the absence of a DAS-28 result. <h3>References</h3> [1]Combe B, Kivitz A, Tanaka Y<i>, et al</i> Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. <i>Annals of the Rheumatic Diseases</i> 2021;80:848-858 [2]Genovese MC, Kalunian K, Gottenberg J, et al. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. <i>JAMA.</i> 2019;322(4):315–325. doi:10.1001/jama.2019.905 Title: Filgotinib for Rheumatoid Arthritis - an observational study to assess clinical effectiveness in NHS Lothian. Christopher D Box, Ewan L Swann, Helen E Harris, Neil D McKay. Author affiliations: Rheumatic Diseases Unit, Western General Hospital, Edinburgh. Acknowledgements: DOI: We received funding for data collection for from Galapagos NV. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Christopher Box: None declared, Ewan Swann: None declared, Helen Harris: None declared, Neil McKay Speakers bureau: Presentations at academic virtual meetings for GIlead in 2022, Grant/research support from: I process sponsorship/ research payment for Educational courses and research from a wide range of pharmaceutical sponsors.